In order to provide clear and practical guidelines for infection control practitioners and others working in the operating theatres, the Hospital Infection Society (HIS) established a Working Party (WP) on Infection Control in the Operating Theatres in 1999 to examine many of these issues.
Three subgroups were established with the following remits,

1
to review the scientific and other evidence for current infection control practices in theatre and following this, to make recommendations on which practices are essential, which are preferred and which are optional or are of little perceived benefit.

2
to produce rational, feasible and applicable guidelines for the environmental monitoring (including bacteriological air sampling) of operating theatre facilities, and specifically to address when monitoring is indicated, how it should be carried out and what action should follow if abnormal.

3
to consider optimal theatre facilities including when ultraclean or plenum theatre ventilation is required in the light of recent changes in surgical practice such as the increasing use of minimally invasive surgery.

The following document is the report from Group 1.
The report from Group 2 can also be viewed on the HIS Website. Work in Group 3 is on going and the conclusions reached will be available on the HIS Website in the next 12 months or so.

The Working Party included microbiologists/infection control doctors, an infection control nurse, an operating theatre nurse, general surgeon, orthopaedic surgeon, aerobiologist, engineer and a representative of NHS Estates. The members of the Working Party were: Gordon Bannister, Alan Bennett, Terie Chesworth, Marjory Greig, Peter Hoffman, Liz Jones, Geoff Ridgway, Hilary Humphreys (Chair), Edward Smyth, Andrew Stacey (Honorary Secretary), Eric Taylor, Kate Woodhead, Chris Dobson and John Williams. The WP reviewed the literature in the relevant areas so that as far as possible the guidelines would be evidence based.
Members of the WP also consulted with other health care professionals as appropriate and achieved consensus following discussion amongst the members on areas where scientific evidence was not available.

Draft documents were widely circulated to professional groups and organisations seeking comment and suggestions, and posted on the HIS Website in early 2001.
During the second half of 2001, the documents were revised in the light of this feedback, circulated to WP members and what follows is the result of this wide consultation exercise.

1.
Introduction

Myths and rituals abound in operating department practice, as demonstrated by anecdotal evidence and current literature.
Redfern1 describes a study in which only 12% of practitioners based infection control (IC) practice in the Operating Theatre on evidence.
Wicker2 describes ‘sacred cows’ of IC behaviour in perioperative practice, and Parker talks of ‘ritualistic practice.’3

Myths have developed as historical narratives or true stories which gradually become part of a culture or institution4. Rituals are described as any action performed according to custom, without understanding the reasons why it is being practised.
Words which may be associated with ritualistic behaviour
are: protocol, routine, tradition and habit.
There are however references to the comfort and familiarity of ritualistic behaviour, enabling staff to standardise processes and systems of care. Wicker2 describes situations which may be more efficiently handled, particularly if they are unpleasant, by standardised behaviour. He also mentions that ‘sacred cows’ are not confined to nurses alone and that medical staff like them as well. Holland5 concludes that some elements of ritualistic practice can be harmless, perhaps even beneficial.

The Working Part has attempted to review the scientific evidence for many of the rituals we practise in our operating theatres and to indicate the strength of that evidence.
The recommendations were categorized according to those used by epic-Developing National Evidence-Based Guidelines for Preventing Health Care associated Infections6.
These are:

Category 1:
generally consistent findings in a range of evidence derived from a majority of acceptable studies.

Category 2:
evidence based on a single acceptable study, or a weak or

inconsistent finding in multiple acceptable studies.

Category 3:
limited scientific evidence that does not meet all the criteria

of 'acceptable studies,' or an absence of directly applicable studies of

good quality.
This includes expert opinion derived from systematically retrieved and appraised professional, national and international publications.

To ‘debunk’ some of the myths and rituals of our daily practice for which there is no evidence or scientific basis may seem sensible but it must be done against a basis of sound infection control and maintain the safety of both patient and healthcare professional. It should also be against a background that recognises the importance of care, concern and discipline in the operating theatre department. The working party recognises that the benefits of good infection control practice are team based, and
rely on all team members having similar standards of understanding and knowledge. Whilst individual aspects of practice may be subject to recommendations within this document, patient outcome is affected
by the good practice by all members of the team. Practice principles should therefore be set and mutually agreed by the team, with advice and guidance from the local Infection Control Team.

2.
Infection Control Policy

Sound infection control practice should be based on available evidence and consistent policy implementation by all healthcare professionals. Recent reports7 have re-iterated the significant costs to patients if best practice standards are not followed. The report suggested that every infection acquired by a patient should be considered a potentially fatal, life long or life threatening complication of hospitalisation or surgery.

Every Operating Department should develop its own IC policy manual. The National Audit Office report7 suggests that 95% of NHS Trusts in England have Manuals for Infection Control but that 8% of these had not been updated during the last four years and are seriously out of date. The report suggests that time could be saved and consistency achieved if an Infection Control Manual were developed by the Department of Health, to save ‘re-invention of the wheel’. They commend the Scottish Office Scottish Infection Manual8 which was published to “provide guidance on core standards for the control of infection in hospital, health care premises and the community interface”. It was issued and will be amended centrally, all Health Boards and hospitals in Scotland are expected to conform to it.

The Report states that in recent visits to NHS Trusts it found IC manuals were not easily accessible.

Reasons for the reduced use of manuals are:

•
there were insufficient number of copies,

•
staff did not know where copies are kept

•
staff
were discouraged by
the sheer bulk of some volumes

The use of hospital intranets to disseminate information and to maintain up to date policies is cited as a way of gaining acceptance and increasing the use of IC policies within Trusts.

2.1
Precautions – Universal or Standard

The risk of infection is included in the UK Health and Safety legislation, in particular the 1999 COSHH Biological Agents Approved Code of Practice.9
The legislation states that “a suitable and sufficient assessment should always be made, though the scope for risk reduction and the range of applicable control measures, and therefore the level of detail required in the assessment, may be less for an activity in category ii than for one in category iii.”
(Category ii is where exposure does not arise out of the work itself but is incidental to it, an example of which is given as health care. Category iii is where there is a deliberate intention to work with a biological agent, as in a microbiology laboratory)

The concept of
“Universal Precautions” (UP), which suggests that all patients be treated with “full” infection control precautions, is not in accord with UK legal Health and Safety philosophy.
Indeed UP have been replaced in the Centers for Disease Control recommendations for Isolation Precautions by “Standard Precautions”, with additional precautions as and when judged appropriate.10

It seems appropriate, after “suitable and sufficient” risk assessment, to adopt precautions for specific procedures in individual patients.
Within any one category of operation there is a standard set of generic precautions deemed appropriate for that procedure, with additional, specific precautions
for different patients or variations in procedure.
Precautions could be based on the likelihood of the presence of an infectious agent, the nature of the infectious agent (i.e. how infectious it is) and the likelihood of dispersion (splashing, dispersal by power tools).

Precautions that prevent liberation of an infectious agent should take precedence over control of that agent once liberated which, in turn, take precedence over individual protection using personal protective equipment.

Recommendation: Category 3

That a standard set of precautions be established for every invasive procedure, with additional risk assessment of each patient to determine extra and specific precautions that may be appropriate.

3.
Theatre Rituals

There are many rituals in the operating theatre that have evolved under the pretext of preventing post-operative wound infection.
Whilst there is little doubt that the degree of bacterial contamination of the operative wound is the major determinant of the incidence of post-operative infection, the virulence of the organisms contaminating the wound, the amount of tissue trauma, and the body’s ability to resist that contamination are all important factors.
The skill of the surgeon undertaking the operation is reflected not only in the degree of trauma that he/she causes but also in his/her general conduct of the operation and awareness of what is, and what is not, important in reducing bacterial contamination of the wound. Maintenance of infection control discipline by all members of the team is important to the patient outcome.

3.1
Rituals in Patient
Preparation

3.1.1
Patient personal clothing

A recent editorial from Canada11noted no increase in infection rates in patients undergoing day-case cataract removal when the patients remained fully dressed to enter the theatre, including their ordinary shoes.

Brown12 describes the ritual of making patients coming to the operating theatre remove their underwear as the “most illogical of rituals”. It is still practised in many surgical units and should be stopped for the good reason that it causes embarrassment to the patient and serves no useful purpose.
Patients are also often required by hospital policy to wear a hat to cover their hair, during surgery. There is no evidence to suggest that the patients’ hair is the cause of an increase in infection in the Operating Theatre, and it would seem sensible therefore to cease this unnecessary practice.

Recommendation: Category 3

The current practice of divesting patients of all their clothes may be unnecessary. Further work is required to confirm this.

3.1.2
Patients Jewellery

The literature suggests that jewellery should be removed where possible13,14, but plain wedding rings could be taped to the patients’ finger if necessary. Ring taping is not for infection control purposes but to stop the rings being lost in the drapes.15 Ring removal can be very traumatic for patients, and Redfern1 suggests that rather than putting the patient through this distressful process, a thorough handwash prior to surgery would be an effective alternative.
There is no evidence in the literature to guide advice on the management of rings or jewellery at other sites – nasal studs, navel rings, nipple rings etc., but there would seem to be no reason to remove these unless they are directly in the field of operation. In the absence of specific infection evidence, a consistent management policy should be developed related to preoperative preparation of the patient.

Recommendation: Category 3

There is no reason to continue the practice of removing the patients rings or other jewellery unless they are in the operative or anaesthetic field.

3.1.3
Shaving

It has long been tradition that the patient should be shaved pre-operatively in the belief that removal of the hair reduces the incidence of wound infection.
Shaving was traditionally done on the night prior to operation.
This method of hair removal can injure the skin, however, and such injury may cause increased risk of infection by producing microscopic infected lacerations by the time of operation.
The benefit of the use of depilatory creams was demonstrated in 1973 by Cruise and Foord.16
They found an infection rate of 2.3% in patients who were shaved but only 1.7% in patients who were not shaved but had their hair clipped, whilst in those patients who were neither shaved nor clipped the infection rate was 0.9%.

A number of other studies have been undertaken: de Koos and McComas17 and found no difference in the incidence of postoperative infection between shaving and chemical depilation in 253 patients but they noted that the depilatory cream saved time by allowing the hair to be removed the day before operation and was advantageous in areas that were difficult to shave.
Zentner et al18 showed a lower incidence of infection in patients who were wet shaved over those dry shaved but this difference did not reach statistical significance.
Seropian and Reynolds,19 in a study of 406 clean wound operations, reported patients shaved had a 5.6% incidence of infection whereas those not shaved or where a depilatory cream was used the incidence of infection was 0.6%.
The hard, chitinous surface of a hair is easier to clean with the skin preparation solution than the skin on which it grows.

Oie and Kamiya have investigated the bacterial contamination of brushes used for shaving and found heavy contamination.20
They recommend shaving foam be used.

A study by Alexander et al21 examined infection rates in 1013 patients undergoing elective surgery who had their hair removed by either clipping or shaving the night before or the morning of operation. Fewer infections were found both at discharge and 30 days after surgery in the group that had hair removal by clipping on the morning of surgery.

Recommendation: Category 1

Only the area to be incised needs to be shaved and, if this cannot be done by depilatory cream the day before operation, it should be done in the anaesthetic room immediately pre-operatively, using clippers rather than a razor.
Shaving brushes should not be used.

1.
Avoid shaving if at all possible

2.
Use depilatory cream, if this is not possible, use clippers

3.
Only shave if other options are not possible

3.1.4
Pre-operative Showering

The patients’ skin is a major source of bacterial contamination in clean wound operations.
It was traditional to ask the patient to bathe or shower before elective surgical procedures but there is no evidence to suggest this influences infection rates.
Cruise and Foord16 showed that the use of hexachlorophene soap had a small effect in reducing infection rates and chlorhexidine showers became an important part of the pre-operative preparation of the patient.

Ayliffe22 found that pre-operative washing with an antiseptic did not reduce the infection rate but Hayek23 showed a reduction in infection when chlorhexidine was used – 9% compared with 12.8% using normal bath soap, and 11.7% in placebo groups.
In Hayek’s clean wound group the infections were 7.2%, 10.2% and 10% respectively.
Byrne et al24 showed in a study of ten healthy volunteers that the greatest fall in bacterial skin flora was achieved by the first and second showers and that there was no further significant fall with subsequent showers.
From this study they recommended that each patient undergo three pre-operative showers with 4% chlorhexidine detergent.
However, when this same group studied the effect of chlorhexidine showers on 3482 general surgical patients in the clean or clean-contaminated categories they found no significant difference in the incidence of wound infection and concluded that pre-operative whole body disinfection with chlorhexidine detergent was not a cost effective treatment for reducing wound infection.25

Garibaldi et al,26 however, showed that 4% chlorhexidine showers reduced both pre-operative and intra-operative skin contamination.
The incidence of a positive intra-operative wound culture was 4% with chlorhexidine and 9% with povidone-iodine and 15% with medicated soap and water.
However, these authors do not report the incidence of post-operative wound infection and whether this was related to this contamination.

In a study of 64 patients undergoing vascular surgery reported by Earnshaw et al,27 the wound infection rate was higher after chlorhexidine baths (26%) than after baths with non-medicated soap (11%).
However, this difference did not reach statistical significance in such a small study.
Kaisar et al28 found chlorhexidine more effective than povidone-iodine in reducing the skin count of staphylococcus and also found that repeated applications of chlorhexidine were more effective than a single shower.

Repeated chlorhexidine showers appear to reduce the bacterial count from the skin particularly of staphylococcus, but there is little evidence that this makes significant reduction to the incidence of postoperative infection and has not been found to be cost effective in the UK.
In one study of vascular surgical patients27 there was a higher incidence of postoperative wound infection in the group that used chlorhexidine than those who used soap but this may be related to the distal infection in the leg and contamination of the wound via lymphatics.

Recommendation: Category 1

There is no evidence that chlorhexidine showers reduce the incidence of postoperative infection.

3.2
Rituals at the operating table

3.2.1
Preoperative hand hygiene

It is important for the surgeon to wash his/her hands prior to operating.
How long the
preoperative wash or 'surgical scrub' should be and what type of antiseptic should be used is not so universally agreed.
Any agent or method of skin decontamination which causes skin abrasions should not be used and using a scrubbing brush on the skin is not recommended.
Dineen29 found no significant difference between a 5 and a 10 minute handwash.
Rehork and Ruden30 using a 5 minute initial wash found that if the operation was of less than an hour duration the wash prior to the next operation need only be for 1 minute but for operations of more than one hour the results were inconclusive and a longer wash may be required. Perira, Lee and Wade31 compared a 3 minute wash and a 30 second subsequent wash, with a 5 minute initial and a 3 minute subsequent wash.
They also compared 4% chlorhexidine gluconate with 7.5% povidine-iodine.
Their optimal regimen was 5 minutes initially followed by the 3 minute wash using chlorhexidine gluconate. Washing for 2 minutes is at least as effective as the 10 minute wash in reducing hand bacterial colony counts but the optimal duration of washing is not known.32 The first wash of the day should include a thorough clean under the fingernails. A brush or orange stick can be used.

Alcoholic hand rubs are increasingly available as alternative products for hand hygiene for ward use32.
The application of alcohol as a gel,
foam,
or as a liquid to clean hands is highly effective at destroying micro-organisms on skin surfaces. Ethanol or isopropanol, 60-80%, are even more effective than detergents or antiseptic soaps, if applied to clean hands. These products may be considered by Infection Control Teams for specific situations within Operating Theatre Practice.33, 34 The recent British Medical Journal editorial recommended that alcohol hand rubs should replace washing as the recommended method of hand hygiene on the wards 35 , and their use is considered adequate in the operating theatre between cases where the surgeons hands are clean and have already been decontaminated by conventional methods

Recommendation : Category 3

Hand
decontamination is an important contributor to reducing infections.
There is no evidence that more than a two minute wash (decontamination) using aqueous disinfectants is required, before any procedure regarded as ‘sterile’.
Alcoholic hand rubs are an acceptable alternative to repeated washing.

3.2.2
Skin Preparation at Operation

In 1960 Lilly and Lowbury 36 showed that 1% iodine in 70% alcohol and 0.5% chlorhexidine in 70% alcohol were the two most effective skin antiseptics for preoperative hand decontamination by the surgeon and ‘scrub’ nurse.
These two antiseptics have become popular for use for skin preparation of the patient in the operating theatre but a number of accidents have been reported in which diathermy sparks have caused the alcoholic vapour to explode.
Gilliam and Nelson37 have shown that a two stage skin preparation with aqueous iodophor scrub and iodophor solution to be as effective as a one step application of iodophor in alcohol solution.
However, they recommend the alcohol solution has been more convenient, easier to apply, less time consuming and potentially less expensive.

Ritter et al38 assessed the bacteriological effect of eight different skin preparation agents – one triclosan compound, one hexachlorophene compound and six iodophors.
They found that two of the iodophors, when applied as sprays, demonstrated excellent bactericidal activity, were less time consuming and were easier to use than compounds which were traditionally applied.
There was no significant difference in the infection rate with any of the agents.

The ideal antiseptic should possess the following properties:

•
The spectrum of activity should be broad, with rapid and persistent effects against Gram negative and Gram positive bacteria (and against fungi and viruses which are resistant to some antiseptics).

•
It should be resistant to inactivation by organic materials, such as blood and faeces

•
There should be no toxicity or allergic reaction

•
Cosmetically acceptable

Ideally antiseptics should be supplied at ready-for-use dilution in small, single-use containers with dispensers attached where necessary.
Multiple-use containers are liable to contamination each time they are opened and the re-use of hand pumps and topping up of half-used containers has been implicated in outbreaks of infection by resistant organisms that can multiply in antiseptic solutions.39
Antiseptic ‘cocktails’ should not be used because many antiseptics are mutually inactivating.
For this reason if several consecutive applications are made to the same body site, the same agent should be used.

Gross contamination at the site of incision should be removed before the antiseptic skin preparation.40 The antiseptic skin preparation should be performed in concentric circles moving away from the proposed incision site to the periphery allowing sufficient prepared area to accommodate an extension to the incision or new incisions or drain sites to be made.41
The application of the skin preparation may need to be modified according to the condition of the skin (eg burns) and the location of the incision site (eg face).
Sufficient time must be allowed for alcohol based skin preparation to dry thoroughly before commencing the procedure to ensure that all combustible ingredients have evaporated.

Recommendation : Category 2

Alcohol solutions are preferred to aqueous solutions for skin preparation but it is important to allow the alcohol to dry after application and before the use of electrocautery.
Solutions should be available in single-use sachets and not multi-use bottles as these may become contaminated on repeated opening. Where multi-use bottles have to be used they should be used within the ‘Use by Date’ and should not be refilled.

3.2.3
Protecting the wound

The bacteria that cause post-operative surgical wound infection can arise from a number of sources, generally classified into endogenous or exogenous.
Endogenous contamination arises from the patient’s own bacterial flora.
Sites from which contamination arises include the skin, nares and the bacterially colonised tracts of the body – gastrointestinal tract, the genito-urinary tract, the bronchial tract, the sinuses and antra of the skull and the diseased biliary tract.

Alternative sources are exogenous, that is from the environment in which the operation is conducted.
Sources here include the instruments used to perform the operation or from the hands of the surgeon and other healthcare workers involved in the procedure.
However, the major exogenous source is transmission by air.
The air introduced by the ventilation system in the operating theatre should be passed through bacterial filters and this is dealt with elsewhere in this report.
Other sources of airborne bacteria are the skin and hair of the healthcare workers present in the operating theatre being shed into the atmosphere and circulated into the wound.
Caps, gowns, masks are designed to prevent such shedding.
Caps and gowns are dealt with elsewhere, as is the use of surgical gloves.

It is traditional that sterile linen is used to drape the patient around the operating area and the surgeon, scrub nurse and scrubbed assistants all wear sterile gowns.
However perhaps 95% of post-operative wound infections are caused by endogenous bacterial contamination of the wound.
It is therefore reasonable to expect that any assessment of the efficacy of different types of linen, surgical gowns, etc., should be undertaken purely on those patients having “clean” wound operations where endogenous contamination is minimal and there should be no contamination other than from the patient’s skin.

3.2.3.1 Surgical drapes

The traditional use of a waterproof sheet over the caudal end of the wound – where instruments are frequently laid, is based on the philosophy that this area gets moist and the instruments can be contaminated by bacterial strike-through.
If this is valid for the caudal end of the wound it is probably valid for all sides and ends of the wound.
See section 3.2.7 on surgical linen.

3.2.3.2
Adhesive Sheets

Thin transparent plastic adhesive incise drapes were introduced in the 1960s.
They adhere to the whole operative field and to the surrounding disposable or reusable linen drapes avoiding the need for towel clips.
However, there was no evidence that they reduce the incidence of post-operative wound infection.
Antiseptic impregnation of these drapes with povidone iodine has been tried but again, although reducing a skin bacterial count, they do not appear to reduce the incidence of infection.24

Johnston et al42 examined the rate of recolonisation of the skin surface after different skin preparations. Recolonisation of the skin surface was reduced by the application of an idophor impregnated incise drape compared with other skin preparation methods. The results showed a significantly reduced rate of recolonisation of organisms on the skin surface that could be mechanically transferred to the wound edge but these authors did not investigate changes in the incidence of subsequent wound infection

3.2.3.3
Wound Guards

Polymeric sheet placed over the wound edge with an attached ring within the peritoneal cavity to hold these in place appear to reduce bacterial contamination of the wound during open bowel surgery but, again, no reduction in the incidence of wound infection has been demonstrated.
In a randomised controlled study Psaila et al43 showed no difference between adhesive plastic drapes with or without an internal plastic ring protector and patients having standard cloth towels.
Nystrom et al 44 in a study of 140 patients showed that the wound ring drape prevented neither contamination nor infection of the wound in colorectal surgery. In contrast, Sookhai et al45 have shown in a recent paper that an impervious wound edge protector reduced the incidence of infection after trans-abdominal surgery in 352 patients with gastro-intestinal disease.
The use of the wound edge protector in this study produced an 84% reduction in post-operative wound infection rate in the contaminated group when compared with those in which a wound protector was not used.
This has clear financial implications but in view of the extensive literature with conflicting results further work would seem necessary.

Recommendation
Category 1

There is no clear benefit from the use of adhesive or other wound edge guards.

3.2.4
Gloves

Gloves play a dual role:

•
as a barrier for personal protection from patients' blood and exudates

•
to prevent bacteria from the surgeon's hands from entering the surgical site.

Randomised studies within various surgical specialities have shown that wearing two pairs of gloves decreases leaks by 3-9 fold in water permeability tests, when compared with wearing one pair of gloves46.
Double gloving may be uncomfortable, reduce manual dexterity and tactile sensitivity but it provides increased protection from penetration of needlestick injuries.47 The use of double gloves also reduced the percentage of hand contamination .48
All examination and surgical gloves must conform to BS EN 455-2.
‘Scrub’ team members should wear sterile gloves donned after the sterile gown. A fresh pair of sterile gloves should be worn for each procedure.
It has been traditional teaching that gloves should be changed promptly if punctured.49
However Dodds et al demonstrated no increase in bacterial contamination of the surgeons hands or the outside of the surgical gloves in operations where gloves were shown to be punctured, and could find no association between glove perforation and postoperative wound infection.50

Recommendation: Category 1

Wearing double gloves at surgical procedures helps to protect the wearer from viral transmission. There is no evidence that perforated gloves increase the incidence of infection and needle puncture of a glove is not an indication to change gloves.
If any action is taken it is preferable to don a second pair of gloves to protect the operating surgeon or individual undertaking the procedure.

3.2.5
Face Masks

The use of masks to reduce post-operative wound infections is questionable. Orr 51 reported that there was no increase in infection rate when masks were not worn for general surgery.
Bacterial shedding onto the operative field was found by Berger et al52 to be significantly higher when no mask (as compared to a full mask) was worn.
However, a relationship between contaminant density and wound infection rate could not be established.
Oral microbial flora dispersal by unmasked male and female volunteers, standing one metre from the table, failed to contaminate exposed settle plates placed on the operating table.
Mitchell and Hunt53 suggested, therefore, that the wearing of face masks by non-scrubbed staff working in an operating room with plenum ventilation appears to be unnecessary.

A controlled, prospective study by Tunevall54 recorded incidence of wound infection in 3,088 patients over a 2 year period in acute and general surgery.
The study design randomised patients into weeks during which staff were 'masked' or 'unmasked'.
Results were statistically insignificant.
The 1,537 'masked' operations having an infection rate of 4.7% compared with 1,551 'unmasked' operations with an infection rate of 3.5%.
However, McLure et al55 demonstrated that facemasks significantly reduced the number of bacterial colonies on the operating field.

Masks not only provide a barrier for airborne organisms but also protection for the wearer against blood and body fluid splashes.
Risk assessment of such invasive procedures indicates the need for personal protective equipment to be worn by any member of the team undertaking a sterile procedure.56
There is a need for staff to be protected from inhalation of surgical smoke and laser plumes. 57

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